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NCT07303738 · ClinicalTrials.gov registry record · Phase 4
The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)
A Phase 4 study of Gastrostomy and Aspiration, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT07303738: Recruiting Phase 4 study of Gastrostomy and Aspiration, sponsored by Boston Children's Hospital.
NCT07303738 is a Phase 4 study of Gastrostomy and Aspiration that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 60 participants, below the 266-participant average among 5 other Gastrostomy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07303738, a Phase 4 study of Gastrostomy and Aspiration, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid concentrations between participants over the 4 hour post-prandial timeframe. Participants who regularly receive an amino acid-based formula will receive an amino acid-based formula during the study and participants who regularly receive a blenderized feed will receive a blenderized feed during the study. Only participants who regularly receive blenderized feeds will be randomized to receive either the high or low bile acid binding blenderized feed.
Primary Outcome
Mean difference in gastric bile acid concentrations between start of feed and four hours following feed
Conditions Studied
Interventions
- DRUG amino acid based formula (e.g. Elecare Jr)
- DRUG low bile acid binding blenderized diet (e.g. Kate Farms)
- DRUG high bile acid binding blenderized diet
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2030-08 |
| Phase | Phase 4 |
What NCT07303738 shows while recruiting
NCT07303738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 266-participant average among 5 other Gastrostomy trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Gastrostomy appearing as the primary indexed condition, and to 3 interventions - of which amino acid based formula (e.g. Elecare Jr) is the first listed.
NCT07303738 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07303738 about?
NCT07303738 is a clinical study titled "The Use of High Bile-binding Foods to Reduce Upper Gastrointestinal Bile Acid Concentrations (Aim 1)". We will perform an acute physiology study comparing three different diets-an amino acid-based formula, a low bile acid-binding blenderized diet, or a high bile acid-binding blenderized diet administered through gastrostomy tube. We will determine the differences in gastric and salivary bile acid con...
What is the current status of trial NCT07303738?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2025-12-01. Estimated completion is 2030-08.
What conditions does trial NCT07303738 study?
This clinical trial studies the following conditions: Gastrostomy, Aspiration, Feeding Difficulties.
What interventions are being tested in trial NCT07303738?
The interventions under investigation include: amino acid based formula (e.g. Elecare Jr) (DRUG), low bile acid binding blenderized diet (e.g. Kate Farms) (DRUG), high bile acid binding blenderized diet (DRUG).
Who is sponsoring clinical trial NCT07303738?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07303738 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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